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         Clinical intelligence for supply chain leadership


hpnonline Daily Update


January 26-30, 2014
January 26 January 27 January 28 January 29 January 30

January 30, 2015   Download print version

FDA takes steps to improve reliability of automated external defibrillators

Hygienically Clean Advisory Board introduces new, stringent testing protocols for healthcare laundries

Medline to bring supply chain expertise and savings to Blood Centers of America as new supply partner

CDC installing cameras in labs in agency-wide safety push

Patients respond to 'expensive' drug better than 'cheap' one

Up to six million households facing penalty for skipping health insurance

How (and why) chemists figured out how to unboil an egg

Marketer who promoted a green coffee bean weight-loss supplement agrees to settle FTC charges

FDA takes steps to improve reliability of automated external defibrillators

The U.S. Food and Drug Administration announced that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency’s strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use.

Automated external defibrillators are portable, electronic medical devices that automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms. They are often stored in public locations for use in an emergency and, while they can be lifesaving, there has been a history of malfunction issues.

From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.

By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance.

Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until July 29, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by April 29, 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until January 29, 2020. Visit the FDA for the release.



Hygienically Clean Advisory Board introduces new, stringent testing protocols for healthcare laundries

The Hygienically Clean Advisory Board announced new, more stringent testing protocols for its Hygienically Clean Certification for commercial laundry facilities processing healthcare related goods.

Reviewed by a third party, independent epidemiologist, the new protocols are designed to better ensure quantifiable hygienic outcomes for healthcare linens as well as recommendations for best practices for improved hygienic transportation and storage of clean linens and other textiles by commercial laundry services.

The independent certification program was developed by the Advisory Board in partnership with TRSA, the leading global textile services trade association.

In order to clear the initial thresholds of the Hygienically Clean Certification, facilities must submit two random textiles to an independent, TRSA-approved laboratory for bacteriological testing. The samples must pass testing on three consecutive rounds and the facility must pass an inspection prior to qualification.

At the conclusion of the qualification process, facilities must then pass new regularly scheduled testing protocols to maintain the Hygienically Clean Certification. These protocols include instituting the Replicate Organism Detection and Counting (RODAC) microbiological test. Modeled on European standards, facilities pursuing the Hygienically Clean Certification must now submit to RODAC testing four times per year rather than the previous protocol of twice per year.

In addition, the Advisory Board has incorporated United States Pharmacopeia (USP) 62 as an additional layer of testing. USP 62 is a recognized testing methodology for seven different microorganisms most commonly found in healthcare environments. Under the new Hygienically Clean Certification protocols, facilities seeking certification will be required to submit to this new, additional layer of testing twice annually.

The transportation and storage best practices include standards for cleaning of transportation vehicles and their storage containers, as well as proper handling, separation and storage of textiles on delivery to healthcare facilities.

Currently, 50 commercial laundry facilities have earned the Hygienically Clean Certification. Complete information on the program and its newly revised protocols and best practices can be found on the program’s new website at hygienicallyclean.org.

All programs under the Hygienically Clean umbrella will benefit from these changes.

Visit Hygienically Clean for the protocols.



Medline to bring supply chain expertise and savings to Blood Centers of America as new supply partner

Blood Centers of America (BCA), the nation’s largest blood supply network, has selected Medline Industries, Inc., as its exclusive supply partner of phlebotomy and donor screening kits.

The three year agreement, beginning April 1, 2015, will strengthen BCA’s ability to make phlebotomy and donor screening kits accessible to more than 50 member centers, as well as its suppliers and clients, all of which serve hospitals and patients across the country. BCA provides more than 40 percent of the U.S. blood supply.

Medline’s vast logistics network of more than 40 strategically located distribution centers across the country will provide BCA with kits whenever and wherever needed, especially in critical emergencies. The medical supplier, distributor and manufacturer, with extensive supply chain expertise, is built on serving the healthcare industry at a moment’s notice, for crises like Hurricanes Katrina and Sandy, or Ebola preparedness, as well as every day needs across the continuum of care. Visit Businesswire for the release.



CDC installing cameras in labs in agency-wide safety push

The U.S. Centers for Disease Control and Prevention (CDC) has introduced camera monitoring of workers in its highest-level biosafety laboratories as it seeks to restore public faith in its procedures after a series of mishaps, agency officials tell Reuters.

One lab worker inadvertently risked contracting Ebola last month when they worked with the live virus that was supposed to have been inactivated, or killed. Since last June, the Atlanta-based agency has disclosed several incidents, one in which scientists unknowingly sent potentially live anthrax to a lower-security laboratory and another in which a deadly form of bird flu was sent to an external agency's lab.

The mishaps have raised major questions over safety practices at more than 1,000 laboratory and support facilities that make up the CDC, whose role is to monitor and prevent outbreaks of disease.

The move to monitor workers will allow lab directors and senior scientists to ensure they have followed safety protocols exactly, Leslie Dauphin, interim director of laboratory safety. Dauphin, who played a key role in the CDC's initial response to the incidents, would not comment directly on the contents of the Ebola report, but confirmed that no one had been harmed.

The unidentified scientist, who was working with Ebola specimens that were supposed to have been inactivated, wore gloves and a gown but not a protective face mask or other gear recommended for working with live Ebola, the CDC said.

The anthrax and bird flu accidents touched off a congressional inquiry and a pledge from CDC director Dr. Thomas Frieden to overhaul the agency's safety culture.

The selection process for a new permanent lab safety chief could take months, so Dauphin has introduced new safety measures in the interim.

A total of 67 cameras have been installed in key laboratories to help ensure technicians follow protocols, especially the techniques to render dangerous pathogens harmless before they can be transferred to lower-security labs.

The move follows a strict review late last summer of inactivation methods in each high-security lab. Each lab now has a checklist for performing those procedures and it is up to senior scientists and lab directors to make sure each step is performed correctly.

The camera system will enable supervisors outside of a containment laboratory to review the footage and verify that steps were performed correctly, Dauphin said.

The video is transmitted from the containment lab via a Wi-Fi network, she said. The videos can be viewed by a supervisor in real time or later.

So far, the CDC has spent around $84,000 on the camera system, according to CDC spokesman Tom Skinner.

CDC has also formed for the first time an agency-wide group to offer standardized safety training for lab workers. Dauphin said CDC is exploring whether its scientific laboratories should adopt standards set by the Geneva-based International Organization for Standardization (ISO) or another external accrediting group. Visit Reuters for the article.  



Patients respond to 'expensive' drug better than 'cheap' one

The placebo effect is a phenomenon that occurs when giving a fake treatment such as a distilled water or sugar to a patient improves his condition simply because that person believes that the treatment will help him.

Now, a new study shows another instance when the placebo response can be very effective. Researchers have found that when people take a drug that they believe is more expensive than it really is, they are more likely to believe that the drug will work even if it is just a placebo.

For the new study published in the journal Neurology on Jan. 28, Alberto Espay, from the University of Cincinnati's Department of Neurology and Rehabilitation Medicine, and colleagues involved 12 patients with Parkinson's disease to examine the placebo effects of medication cost.

The researchers told the participants that they would be given two variations of the same drug but the other one was more expensive compared with the other. The participants were told that the cheaper drug costs $100 while the more expensive one was $1,500. The researchers also said that the purpose of the study was to determine if the two drugs are similar in efficacy regardless of the difference in price albeit all the participants were only given saline solutions.

The participants underwent several tests that would measure their motor skills as well as brain scans for measuring their brain activity before and after they were injected with the placebo.

The researchers found that although both placebos have improved the participants' motor functions, those who received the costlier drug first exhibited up to 28 percent improvements in their motor skill. In comparison, participants who received the cheaper drug only improved by 13 percent.

The researchers said that the participants experienced a great placebo response because placebo has been known to boost the release of dopamine in the brain which affects movement. Visit Tech Times for the study.



Up to six million households facing penalty for skipping health insurance

The U.S. government estimates as many as six million households may have to pay a penalty for not having had health-insurance coverage last year as required under the Affordable Care Act, officials said Wednesday.

About 150 million taxpayers are expected to file returns during the coming tax season, said Mark Mazur, assistant secretary for tax policy at the Treasury Department. The tax-filing process this year is expected to be trickier because Americans will, in some cases, have to pay a penalty or get smaller refunds because credits they received to offset insurance premiums were too large.

Up to 20% of tax filers—or about 30 million—who weren’t insured for most or any of last year likely will request and receive an exemption from the penalty, officials said. Many exemptions can be applied for during the tax-filing process.

The health law requires almost all Americans to have coverage or pay a penalty, with some exemptions. About 2% to 4% of tax filers are expected to have to pay the fine for not having carried insurance in 2014, which is $95 per adult, or 1% of family income, whichever is greater.

Federal officials began in early January mailing statements called 1095A forms to consumers with information they will need to file returns.

Government officials on Wednesday provided some of their first estimates on how Americans will be affected by the ACA at tax time. About three-quarters of tax filers who had coverage in 2014 simply will have to check a box on their federal tax forms indicating they had coverage last year.

About 9.5 million people selected or automatically were enrolled in health-insurance coverage through the second month of the continuing open-enrollment season, the federal government said Tuesday. That included 7.1 million consumers who used the federal HealthCare.gov exchange and 2.4 million people who relied on states using their own marketplaces.

The enrollment numbers cover through mid-January and indicate the Obama administration largely is on track to reach its earlier sign-up goals. The administration said in November that it was aiming for up to 9.9 million paid-up enrollees by the end of 2015. Visit the Wall Street Journal for the report.



How (and why) chemists figured out how to unboil an egg

You can't unscramble an egg. But you can unboil it.

That's what chemists with University of California, Irvine, and South Australia’s Flinders University managed to do, and their findings were published last week in the journal ChemBioChem. All it took was a chemical solution and a machine that spins at high speeds.

The eggs were used as a proxy for a serious endeavor: making cancer research more time and cost efficient. University of California, Irvine, chemistry and molecular biology professor Gregory Weiss wanted to figure out how to refold lab-created proteins associated with cancer. "The problem is when we tried to produce cancer-associated proteins... often times the proteins come out as a jumbled mess," Weiss said. "It kind of looks like boiled eggs... When that happens, we sigh deeply."

It can take days, even weeks, for scientists to tease out those gunked-up proteins that are stuck to the edges of test tubes. Until recently, those proteins were unpacked using dialysis, a method that's been around for more than a century.

So when Weiss visited Colin Raston’s South Australia’s Flinders University laboratory and saw his high-powered, vortex-fluid device that essentially pulls things apart, Weiss thought: why not pull proteins apart?

The saying "you can't unscramble an egg" came to mind; Weiss thought he'd set about proving that wrong. So they took an egg and separated the yolk from the white. The whites boiled for 20 minutes at 90 degrees Celsius until they were rock hard.

The egg whites' proteins had changed shape, but the proteins themselves remained intact -- much like misshapen cancer-associated proteins. So Weiss set about unfolding those egg white proteins back into shape, by first dissolving the boiled egg whites overnight in a urea chemical solution.

Then, he took the mixture, put it into the vortex fluid device, and the whites went for a high-speed, five-minute spin. As the proteins brush up against the test tube walls, the high shear force generated is enough to pull the proteins.

The result was a clear solution that looked just like diluted egg whites. At a molecular level, researchers looked at the protein lysozyme (a pretty important protein in giving eggs their antibacterial property). The process of diluting the egg whites and sticking them in the machine restored lysozyme back to about 85 percent of pre-boiled activity, Weiss said.

"The fundamental principle that we demonstrated was this idea that the proteins have changed their shape but they haven't changed their bonding patterns, their connectivity," Weiss said.

Visit the Washington Post for the story.



Marketer who promoted a green coffee bean weight-loss supplement agrees to settle FTC charges

Lindsey Duncan and the companies he controlled have agreed to settle Federal Trade Commission charges that they deceptively touted the supposed weight-loss benefits of green coffee bean extract through a campaign that included appearances on The Dr. Oz Show, The View, and other television programs.

Under the FTC settlement, the defendants are barred from making deceptive claims about the health benefits or efficacy of any dietary supplement or drug product, and will pay $9 million for consumer redress.

The FTC charged that Duncan and his companies, Pure Health LLC and Genesis Today, Inc., deceptively claimed that the supplement could cause consumers to lose 17 pounds and 16 percent of their body fat in just 12 weeks without diet or exercise, and that the claim was backed up by a clinical study. In September 2014, the FTC settled charges against the company that sponsored the severely flawed study that Duncan discussed on Dr. Oz.

According to the FTC’s complaint, shortly after Duncan agreed to appear on Dr. Oz but before the show aired, he began selling the extract and tailored a marketing campaign around his appearance on the show to capitalize on the “Oz effect” – a phenomenon in which discussion of a product on the program causes an increase in consumer demand.

The defendants continued to use Duncan’s Dr. Oz appearance in their marketing campaign after the show aired, the complaint states, posting links to the episode on websites and using retail point-of-sale displays showing messages such as “New Health Discovery! As Seen on TV, ‘The Dieter’s Secret Weapon.’” After appearing on Dr. Oz, Duncan and his companies sold tens of millions of dollars’ worth of the extract, according to the FTC.

The FTC also alleged that Duncan and several of the companies’ paid spokespeople portrayed themselves on television shows as independent sources of information about green coffee bean extract and other natural remedies, while failing to disclose their financial ties to the companies.

The proposed stipulated court order requires the defendants to substantiate any future weight-loss claims with at least two well-controlled human clinical tests. Any claims the defendants make about the health benefits and efficacy of any dietary supplement or drug cannot be misleading and must be substantiated by competent and reliable scientific evidence. Further, the order prohibits false claims that the benefits of any such product are scientifically proven. Visit the FTC for the full news release.



January 29, 2015   Download print version

Arizona tracking up to 1,000 potentially exposed to California-linked measles virus

Drop in Ebola cases makes scientists wonder if virus immunizes as well as it kills

Largest-ever autism genome study finds most siblings have different autism-risk genes

Smoking may increase risks for patients being treated for prostate cancer

NIH launches tool to advance Down syndrome research

Practice parts for surgeons from a 3-D printer

Controlling your breath is an easy way to improve mental and physical health

Obamacare enrollment nears goal U.S. says

Arizona tracking up to 1,000 potentially exposed to California-linked measles virus

The measles outbreak that originated in California’s Disneyland has now spread to seven people in Arizona, with up to 1,000 people in the state potentially exposed to the disease, including nearly 200 children.

According to public health authorities, there are now 79 confirmed cases in California, 52 that have been linked to Disneyland. In addition to Arizona, cases have been reported in Colorado, Michigan, Nebraska, Oregon, Utah and Washington State — all connected to California, according to state health officials.

This week, two new cases in Arizona — a man and woman — were linked back to a local family reported to be infected when they visited the West Coast amusement park, according to the Arizona Republic. Health officials say the outbreak is a direct result of the increasing number of people — particularly in California — who have chosen to remain unvaccinated, partly because of the erroneous belief that vaccinations can cause autism.

Arizona Department of Health Services director said anyone who is unvaccinated or undervaccinated — those who have not yet received all doses — who has been exposed to the measles must be quarantined for three weeks.

According to the Centers for Disease Control and  Prevention, the measles virus lives in mucus in the nose and throat. When measles patients cough or sneeze, “droplets spray into the air and the droplets remain active and contagious” for up to two hours.

Arizona public health authorities confirmed the woman, who was diagnosed with measles in Maricopa County, had been exposed to the family that recently traveled to Disneyland — ground zero for the current outbreak. Officials said she went on to expose as many as 195 children between Jan. 20 and Jan. 21 at Phoenix Children’s East Valley Center, an urgent care center. It’s still not clear why she was there and whether she was vaccinated, but she has since recovered, according to the health department.

It’s unclear how many people have been exposed to the man who was diagnosed in Pinal County after he came in contact with the same family that had been to Disneyland. Pinal County health officials put out a notice listing five places of business the man had visited and urged people who might have been exposed to him to review their immunization history and monitor themselves “for illness with fever and unexplained rash” until Feb. 13.

The measles outbreak began in December, when someone reportedly infected with the virus visited the Disneyland Resorts in Anaheim, CA. Over the past month, the disease has spread beyond that community, infecting close to 100 people in eight states. Mexico is also now battling the outbreak, according to news reports.

California is working to get ahead of the measles. This week, 30 babies were put in home isolation in Alameda County after possible exposure. The disease is especially dangerous for infants because children younger than one year cannot get the MMR vaccine. On Tuesday, nearly 70 students at Palm Desert High School near Palm Springs were banned from class for two weeks because they haven’t been vaccinated.

Visit the Washington Post for the report.



Drop in Ebola cases makes scientists wonder if virus immunizes as well as it kills

A recent sharp drop in new Ebola infections in West Africa is prompting scientists to wonder whether the virus may be silently immunizing some people at the same time as brutally killing their neighbors.

So-called “asymptomatic” Ebola cases — in which someone is exposed to the virus, develops antibodies, but doesn’t get sick or suffer symptoms — are hotly disputed among scientists, with some saying their existence is little more than a pipe dream.

Yet if, as some studies suggest, such cases do occur in epidemics of the deadly disease, they may be a key factor in ending outbreaks more swiftly by giving secret protection to those lucky enough to be able to bat the infection away.

"We wonder whether ‘herd immunity’ is secretly coming up — when you get a critical mass of people who are protected, because if they are asymptomatic they are then immune," Philippe Maughan, senior operations administrator for the humanitarian branch of the European Commission, told Reuters. "The virus may be bumping into people it can’t infect anymore."

Latest World Health Organization data show new cases of infection in West Africa’s unprecedented Ebola epidemic dropping dramatically in Guinea, Sierra Leone and particularly in Liberia.

Most experts are sure the main driver is better control measures reducing direct contact with contagious patients and corpses, but there may also be other factors at work.

So-called herd immunity is a feature of many infectious diseases and can, in some cases, dampen an outbreak if enough people get asymptomatic, or “sub-clinical” cases and acquire protective antibodies. After a while, the virus — be it flu, measles, polio — can’t find non-immune people to be its hosts.

But some specialists with wide experience of disease outbreaks are highly skeptical about whether this phenomenon happens in Ebola, or whether it could affect an epidemic.

"There is some suggestion there may be cases that are less severe… and there may even be some that are asymptomatic," said David Heymann, an infectious disease expert and head of global health security at Chatham House. "But herd immunity is just the wrong term. There could be household immunity developing, but even that is only hypothesis."

Others are more hopeful and are urging researchers in West Africa to seek out and test possible asymptomatic cases with a view to using the secrets of their silent immunity.

Steve Bellan of the University of Texas in the United States argues that if scientists can reliably identify asymptomatic people, they could help with disease-control tasks like caring for patients and conducting burials, reducing the number of non-immune people exposed in these risky jobs. Bellan points to two studies in particular. One, conducted after an Ebola outbreak in Gabon in 1997, found that 71 percent of “seropositive” people — those with traces of the Ebola virus in their blood — did not have the disease. The other, published in April 2002, found 46 percent of asymptomatic close contacts of patients with Ebola were seropositive. (Reuters) Visit Yahoo for the story.



Largest-ever autism genome study finds most siblings have different autism-risk genes

The largest-ever autism genome study, funded by Autism Speaks, reveals that the disorder's genetic underpinnings are even more complex than previously thought: Most siblings who have autism spectrum disorder (ASD) have different autism-linked genes.

The Autism Speaks MSSNG project data became part of the historic first upload of approximately 1,000 autism genomes to the Autism Speaks MSSNG portal in Google Cloud Platform. Autism Speaks is making the de-identified data openly available for global research in order to speed understanding of autism and the development of individualized treatments.

Autism Speaks' MSSNG program leader Dr. Stephen Scherer, directs the Centre for Applied Genomics at Toronto's Hospital for Sick Children and the McLaughlin Centre at the University of Toronto.

In total, the MSSNG project aims to make at least 10,000 autism genomes available for research, along with a "tool box" of state-of-the-art tools to aide analysis.

In the new study, Dr. Scherer's team sequenced 340 whole genomes from 85 families, each with two children affected by autism. The majority of siblings (69 percent) had little to no overlap in the gene variations known to contribute to autism. They found that the sibling pairs shared the same autism-associated gene changes less than one third of the time (31 percent).

The findings challenge long-held presumptions. Because autism often runs in families, experts had assumed that siblings with the disorder were inheriting the same autism-predisposing genes from their parents. It now appears this may not be true.

"We knew that there were many differences in autism, but our recent findings firmly nail that down," Dr. Scherer says. "We believe that each child with autism is like a snowflake - unique from the other."

"This means we should not be looking just for suspected autism-risk genes, as is typically done in diagnostic genetic testing," Dr. Scherer adds. "A full assessment of each individual's genome is needed to determine how to best use knowledge of genetic factors in personalized autism treatment." Whole genome sequencing goes far beyond traditional genetic testing to analyze an individual's complete DNA sequence.

Known autism-risk genes showed up in 42 percent of the families participating in the study. "This may help explain why autism came about in their child or provide insight into related medical conditions," Dr. Scherer says. In a 2013 pilot genome sequencing study, Dr. Scherer's team identified autism-linked genes in more than half of 32 participating families. That study provided several families with medically important information. Visit Science Daily for the study.



Smoking may increase risks for patients being treated for prostate cancer

Among patients with prostate cancer, those who smoke have increased risks of experiencing side effects from treatment and of developing future cancer recurrences, or even dying from prostate cancer. The findings, which are published in BJU International, suggest that smoking may negatively affect the health outcomes of patients with prostate cancer and may contribute to complications related to their care. 

Several studies have demonstrated links between cigarette smoking and prostate cancer. To better understand the influence of smoking on prostate cancer progression and treatment, Michael Zelefsky, MD, of the Memorial Sloan Kettering Cancer Center in New York City and Professor of Radiation Oncology, and his colleagues studied 2358 patients who underwent external beam radiotherapy for prostate cancer between 1988 and 2005. Of these, 2156 had a history of smoking. Patients were classified as never smokers, current smokers, former smokers, and current smoking unknown. 

Over a median follow-up of nearly eight years, patients who were current smokers had a 40% increased risk of cancer relapse, as well as more than 2-times increased risks of cancer spread and cancer-related death, compared with patients who were never smokers. In addition, current and former smokers had a higher likelihood of experiencing side effects, such as urinary toxicity, related to radiotherapy. Examples of urinary toxicity include urinary retention, urinary incontinence, and bladder hemorrhage.

"Less optimal tumor control outcomes among smokers could possibly be explained by the influence of less oxygen concentration within the treated tumors among smokers, which is known to lead to less sensitivity of the cells being killed off by radiation treatments," Dr. Zelefsky noted. "Our findings point to the importance of physicians counseling their patients regarding the potential harms of smoking interfering with the efficacy of therapies and for increased risks of side effects."

Visit Wiley for the study.



NIH launches tool to advance Down syndrome research

The National Institutes of Health has launched a subsite of DS-Connect: The Down Syndrome Registry for researchers, clinicians, and other professionals with a scientific interest in Down syndrome to access de-identified data from the registry. This Web portal will help approved professionals to plan clinical studies, recruit participants for clinical trials, and generate new research ideas using information gathered from the registry participants.

De-identification is the process of separating personal information from the person who contributed the data. The practice is commonly used to keep health information confidential.

People with a scientific interest in Down syndrome may sign up for a free professional account to access the data. After registering, they can then view information about participants’ health histories, including symptoms, diagnoses, and other medical issues. Researchers may also apply for higher-level access to perform customized searches of the data, propose new survey questions, or identify a pool of participants for a clinical trial. The DS-Connect registry coordinator will then notify eligible participants who have previously indicated a willingness to be contacted about opportunities to enroll in clinical trials.

“DS-Connect allows people to participate from all corners of the globe,” said George T. Capone, M.D., director of the Down Syndrome Clinic and Research Center at Kennedy Krieger Institute in Baltimore. “They answer the same kinds of health questions, and that permits researchers to identify similarities, differences, and important trends in the population that may then be the basis for further, more focused, research studies.”

Results from these studies are intended to increase understanding of Down syndrome and how to treat its accompanying health problems across the lifespan. People with Down syndrome are at increased risk for a range of other health conditions, including autism spectrum disorders, problems with hormones and glands, hearing loss, vision problems, and heart abnormalities.

“For the purpose of conducting clinical trials, the DS-Connect registry can provide a large pool of potential participants who share common features, such as medical condition, age, and gender,” said Dr. Capone.

DS-Connect was launched in September 2013, with input from the Down Syndrome Consortium, a public-private partnership established to foster the exchange of information on Down syndrome research. Visit NIH for more information.



Practice parts for surgeons from a 3-D printer

3-D-printed models are transforming medical care, giving surgeons new perspectives and opportunities to practice, and patients and their families a deeper understanding of complex procedures. Hospitals are also printing training tools and personalized surgical equipment. Someday, doctors hope to print replacement body parts.

“There’s no doubt that 3-D printing is going to be disruptive medicine,” said Dr. Frank J. Rybicki, chief of medical imaging at the Ottawa Hospital and chairman and professor of radiology at the University of Ottawa. He is the former director of the applied imaging science lab at Brigham and Women’s Hospital.

“It makes procedures shorter, it improves your accuracy,” said Dr. Rybicki, who has used 3-D printing in his work with face transplants. “When bioprinting actually hits, it will change everything.”

For now, the printer extrudes a layer of liquid plastic instead of ink. It adds a second layer, and then another, and a skull or rib cage — or whatever the surgeon dials up — slowly emerges. The same process can also print layers of human cells. So far, researchers have also printed blood vessels, simple organs and bits of bone. A Utah boy’s life was saved last year by a 3-D-printed plastic splint that propped open his windpipe.

Dr. Peter Weinstock, the director of the Pediatric Simulator Program at Boston Children’s, sees 3-D models as part of a larger program to improve surgical craft. At Children’s and a dozen other pediatric centers around the world, he says, the surgical simulation program he developed improves team communication and trust, and lifts confidence before extremely complex operations. He believes it also shortens patients’ time under anesthesia.

If the nearly two-year-old program has prevented even one major medical error — and Dr. Weinstock is convinced it has prevented many — it has paid for itself and its $400,000 3-D printer, running nearly full time in the hospital’s basement.

At Brigham and Women’s Hospital, an even more sophisticated 3-D printer replicates flesh as well as bone, and even prints the tools he will use to make the cuts.

Comparing models from before and after surgery also offers clues to why some tissue grafts take hold and some are rejected, Dr. Rybicki said. As 3-D printers improve, so will surgical outcomes, Dr. Rybicki said. Soon, doctors will thread catheters through replica blood vessels, map out how to bypass aneurysms, and feel the tactile difference between tumors and healthy tissue, for instance.

Although there has been little research so far into the benefits of 3-D printing or surgical simulations, Department of Veterans Affairs researchers have shown that teamwork exercises in operating rooms reduced patient deaths or injuries by as much as 18 percent. Visit the New York Times for the story.



Controlling your breath is an easy way to improve mental and physical health

Take a deep breath and relax. Behind that common piece of advice is a complex series of physiological processes that calm the body, slow the heart and help control pain. Breathing and controlling your breath is one of the easiest ways to improve mental and physical health, doctors and psychologists say. Slow, deep and consistent breathing has been shown to have benefits in treating conditions ranging from migraines and irritable bowel syndrome to anxiety disorders and pain.

“If you train yourself to breathe a little bit slower it can have long-term health benefits,” said Murali Doraiswamy, a professor of psychiatry at Duke University Medical Center in Durham, NC. Deep breathing activates a relaxation response, he said, “potentially decreasing inflammation, improving heart health, boosting your immune system and maybe even improving longevity.”

To help foster the habit of healthful breathing, a San Francisco technology startup recently launched a wearable device called Spire that tracks breathing patterns and tells users when they are too tense or anxious. “One of the goals of this work was, ‘How do you make it so simple to shift into calm or focus that people don’t have to stop what they’re doing?’” said Neema Moraveji, co-founder of Spire and director of the Calming Technology Lab at Stanford University.

Many early buyers of the $150 Spire are office workers who spend a lot of time on computers. Research has found people working on computers often hold their breath, an action referred to as screen apnea, he said.

Belisa Vranich, a New York City-based clinical psychologist, has been conducting breathing workshops around the country for just over a year. Dr. Vranich says she instructs clients to breathe with their abdomen. On the inhale, this encourages the diaphragm to flatten out and the ribs to flare out. Most of us by instinct breathe vertically, using our chest, shoulders and neck, she says.

Abdominal, or diaphragmatic, breathing is often taught in yoga and meditation classes. Experts say air should be breathed in through the nose, and the exhale should be longer than the inhale. Dr. Vranich recommends trying to breathe this way all the time but other experts say it is enough to use the technique during stressful or tense times or when it is necessary to focus or concentrate.

Slow breathing stimulates the vagus nerve, which runs from the stem of the brain to the abdomen. It is part of the parasympathetic nervous system, which is responsible for the body’s “rest and digest” activities. (By contrast, the sympathetic nervous system regulates many of our “fight or flight” responses.)

The vagus-nerve activity causes the heart rate to decrease as we exhale, said Richard Gevirtz, a psychology professor at Alliant International University in San Diego. Vagal activity can be activated when breathing at about five to seven breaths a minute, said Dr. Gevirtz, compared with average breathing rates of about 12 to 18 breaths a minute.

The vagus nerve’s response includes the release of different chemicals, including acetylcholine, a neurotransmitter that acts as an anti-inflammatory and slows down digestion and the heart rate, said Stephen Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia who is working on an article on the vagus nerve and its functions.

When medical conditions are severe, such as with epilepsy, medical devices are sometimes implanted to stimulate the vagus nerve. For most people, slow, steady breathing is a natural way to stimulate the nerve.

Certain conditions, including asthma and panic disorders, have been shown to benefit from a different breathing technique—taking shallow breaths through the nose at a regular rhythmic speed of eight to 13 breaths a minute. For these patients, already anxious about their symptoms, deep breathing can cause them to take in too much air and hyperventilate.

Spire, the device that tracks individual breathing patterns, is a pedometer-like device that can be clipped onto pants or a bra strap and can sense breathing patterns without touching the skin. A sensor detects subtle torso expansions and contractions, said Stanford’s Dr. Moraveji. The device identifies people’s baseline breathing patterns and can tell users when they are tense or may need to take a deep breath. It includes an app that guides people in breathing exercises as short as 30 seconds. Visit the Wall Street Journal for the article.



Obamacare enrollment nears goal U.S. says

About 9.5 million people have signed up or renewed their Obamacare insurance coverage for 2015, the U.S. government said surpassing last year’s enrollment total with 2 weeks to go. The government has said it expects 9.1 million people to be paying for coverage in 2015. Because not everyone who signs up will pay their premiums and complete the enrollment process, the administration needs more than 9.1 million to select a plan by Feb. 15.

“We still have a lot of work to do before Feb. 15, but are encouraged by the strong interest we’ve seen so far,” Sylvia Mathews Burwell, the Health and Human Services secretary, said in a statement. Federal officials haven’t said how many people they hope will initially sign up.

It’s the first time the U.S. has reported new health plan enrollment and renewals nationwide for 2015 coverage under the Patient Protection and Affordable Care Act. The figures include 37 states served by healthcare.gov, the federal enrollment system, and 13 states that handle enrollment themselves.

Last year was the first year of coverage under the law, and about 8 million people signed up by May. By Oct. 15, paid enrollment had fallen to 6.7 million as people dropped out or found other sources of insurance, such as through new jobs or from Medicare, the program for the elderly and disabled.

The Congressional Budget Office has estimated larger enrollment numbers than the administration, and in April said 13 million people would be enrolled in private plans sold under the Affordable Care Act in 2015. The Obama administration said the budget agency’s estimate was too aggressive in November, and that the law would take more time reach full enrollment.

On Monday the CBO scaled back its 2015 estimate by a million, to 12 million. The agency also said the health law’s coverage expansions, including from the Medicaid program for the poor, would cost less than it initially projected. It credited new data and changes to the law and its implementation.

Health coverage under the law is expected to cost $571 billion through 2019, the CBO said, a 20 percent reduction from the agency’s estimate in 2010, when Obama signed the measure. Visit Bloomberg for the report.



January 28, 2015   Download print version

Medtronic strategy takes shape after biggest inversion ever

WHO launches emergency Ebola fund to prevent future response blunders

Cleveland hospitals grapple with readmission fines

Common OTC anticholinergic drugs like Benadryl may increase your risk of Alzheimer's

Xenex secures $25 million in funding

White House wants to nearly double funding to fight antibiotic resistance

Budget office slashes estimated cost of health coverage

Mississippi children's hospital plans $150 million expansion

Medtronic strategy takes shape after biggest inversion ever

After pulling off the largest-ever “inversion” deal structured to reduce U.S. income taxes, Medtronic Plc is plotting another audacious move: the transformation of healthcare delivery. The $49.9 billion purchase of Covidien Plc, completed Monday, will cut taxes by moving Medtronic’s headquarters to Ireland. The deal also gives the medical-device maker a wider array of products, enabling the company to work more comprehensively with hospitals to control costs and make care more accessible, Chief Integration Officer Geoff Martha said.

Medtronic is now conducting trials of its products for heart-failure patients, seeking to demonstrate that the devices’ costs are recouped by a longer life with fewer and shorter hospital stays. The tests have been the subject of internal debate at the company, with some executives worried they won’t produce the desired results, Martha said.

The company won’t have to wait to reap the financial benefits of the transaction, said Chief Executive Officer Omar Ishrak. While proving the economic value of its products will eventually make healthcare more efficient, the acquisition provides immediate help in returning free cash to shareholders and boosting earnings, he said in a telephone interview.

Medtronic’s trials are comparing the long-term costs of treating heart-failure patients using traditional techniques against the expenses of using its sophisticated devices, which coordinate the heart’s pumping action and track its function wirelessly. A long-term benefit would help the company get better coverage and higher reimbursement for its products by proving their economic value.

It’s not clear the approach is going to pay off. Many of the services Medtronic is offering, including everything from consultation services to remote monitoring for its sophisticated devices, have been offered for free to keep customers and avoid price cuts, said Jeff Jonas, a portfolio manager at Gabelli & Co. who holds both company’s shares.

The change is opportune. For the first time ever, the U.S. Medicare health insurance program for the elderly will base some reimbursement for treating beneficiaries using novel methods on how well the patients respond. While the agency traditionally pays for each doctor visit, it will now focus on the quality rather than quantity of care.

The deal for Covidien puts Medtronic in a better position to negotiate with hospital administrators, a group that has gained purchasing power as doctors increasingly become employees and hospitals limit what brands they carry, said Joanne Wuensch, an analyst with BMO Capital Markets in New York. The expanded Medtronic will have offerings in six of the top 10 purchasing arms of the hospital, she said.

“They can go in not just with a bucket of products as they have previously, but with a full buffet table,” she said. “It does facilitate the partnership between the device manufacturers and the hospital providers, being able to make more purchases from a fewer number of sellers.”

Medtronic went through with the deal despite resistance from the U.S. government. The Treasury Department proposed changes last year to make transactions less profitable for U.S. companies that shift their legal addresses overseas to avoid paying taxes on foreign earnings.

Medtronic, which will be run from Minneapolis and domiciled in Ireland for tax purposes, borrowed $16 billion to finance the deal after the rule change meant it couldn’t use cash held abroad without paying taxes.

The company has a four-step process to complete the integration of Covidien and its almost 40,000-person workforce in three years, wringing $850 million in cost savings out of the combined companies.

The two companies are already working on ways to collaborate, with Medtronic staff members who are involved with running cardiac catheterization laboratories in Europe counseling Covidien executives on their efforts to do the same thing with operating rooms. Visit Bloomberg for the story.



WHO launches emergency Ebola fund to prevent future response blunders

The World Health Organization (WHO) said on Sunday it will create a contingency fund and an emergency workforce to respond quickly to crises after strong criticism of the agency's delay in confronting the Ebola epidemic.

Director-general Dr. Margaret Chan said at an emergency meeting called to discuss the agency's Ebola response that the outbreak showed the need to strengthen WHO's crisis management and to streamline procedures for recruiting frontline workers.

Ebola has been "a mega crisis and it overwhelmed the capacity of WHO," she told a news briefing. "Member states truly understand that the world does need a collective defense mechanism for global health security."

In the past year, 21,724 Ebola cases have been reported in nine countries and 8,641 people have died, according to the WHO, which says West Africa's outbreak is ebbing.

A resolution seeking major reforms, brought by the United States and South Africa, was adopted by consensus at the meeting of the 34-member executive board.

"The WHO we have is not the WHO we need, not the WHO we needed to respond to health emergencies of the magnitude of Ebola," Tom Frieden, director of the U.S. Centers for Disease Control (CDC), told the talks. In the debate, he said that political considerations often overruled technical expertise at the United Nations agency.

Major donors welcomed agreement on the emergency fund, which a WHO committee had recommended in 2011 should contain $100 million after the 2009-2010 influenza pandemic. Chan told reporters that the figure was "a good starting point."

Bruce Aylward, WHO assistant director-general in charge of the Ebola response, said the agency would need about a workforce of about 1,500 for such emergencies, up from 1,000 currently. Visit Huffington Post for the report.



Cleveland hospitals grapple with readmission fines

Since the Cleveland Clinic began sending pharmacists into cardiovascular patient rooms at discharge, it has drastically reduced its number of readmissions. And that means it has reduced its Medicare fines, mandated by the Affordable Care Act. But this kind of success in the ACA’s readmissions program, now in its third year, has been hard to achieve for other Cleveland hospitals that serve more poor patients.

This month, the National Quality Forum began a two-year trial period that adjusts Medicare’s metrics to account for poorer patient populations. NQF is a not-for-profit advisory group that works with federal regulators on the penalty metrics.

NQF’s Chief Scientific Officer Dr. Helen Burstin says one main question is being asked: “How much should these issues around socioeconomic status (and) poverty be considered as well for the readmission program?” During the trial period, researchers will gather data on which penalty measurements are related to poverty and how they could be risk adjusted, Burstin says.

“Socioeconomic status may be a proxy for some other really important factors, such as whether somebody has social support at home, whether somebody has the ability to come back and have a follow-up appointment with their doctor after hospitalization,” she says.

The key, Burstin says, is to understand which factors hospitals could be accountable for improving.

Burstin says federal regulators at the Centers for Medicare and Medicaid Services are part of the discussions and “willing to participate in the trial going forward.”

Unlike the Cleveland Clinic, MetroHealth has seen its Medicare fines increase since the program began in 2012. MetroHealth had a .83 percent cut in Medicare reimbursement for 2015, as compared with a .45 percent in 2013. Since 2013, the Clinic’s main campus has seen its penalty drop to .38 percent of Medicare payments from .74 percent.

The penalties were originally based on readmissions of Medicare patients who went into the hospital with one of three conditions – heart attack, heart failure and pneumonia – and returned within 30 days. Now, federal regulators are also including readmissions for hip/knee replacement surgery and chronic obstructive pulmonary disease, or COPD.

Leaders at Cleveland-area hospitals say that regardless of the amount of care and coaching a patient gets in the hospital, a patient’s home environment is critical. Visit Kaiser Health for the report.



Common OTC anticholinergic drugs like Benadryl may increase your risk of Alzheimer's

Anticholinergic medications span a range of common drugs and include antihistamines, sleep aids, antidepressants, cardiovascular meds, gastrointestinal drugs (for diarrhea, incontinence, diverticulitis, and ulcers), and muscle relaxants. Now, a new study confirms the link between these everyday medications and dementia.

Taking anticholinergic drugs at high doses or for a long time may significantly increase your risk for developing Alzheimer's disease and other dementias, say researchers from University of Washington School of Pharmacy.

On average, older people take four or five prescription drugs and two over-the-counter drugs each day. Clearly, drugs are an important part of medical care for older people; however, older people are more sensitive to the effects of many pills, including anticholinergics, which block the neurotransmitter acetylcholine and so affect the nervous system. While the drugs are too numerous to mention, those with anticholinergic effects — and these effects are sometimes dependent on the dose —include Benadryl, Sominex, Xanax, Ativan, Valium, Luminal, Skelaxin, Limbitrol, and Tavist.

For the current study, the researchers investigated a previously reported link between anticholinergics, both prescription strength and over-the-counter, and dementia by employing more rigorous methods than in the past. Specifically, the researchers conducted a longer follow-up of more than seven years and more accurate use assessment via pharmacy records, which included nonprescription choices.

The most commonly used medications in the study, the researchers discovered, were tricyclic antidepressants like doxepin (Sinequan), antihistamines like chlorpheniramine (Chlor-Trimeton), and antimuscarinics for bladder control like oxybutynin (Ditropan). People taking at least 10 mg/day of doxepin, 4 mg/day of diphenhydramine, or 5 mg/day of oxybutynin for more than three years, the researchers estimated, would be at greater risk for developing dementia.

Importantly, substitutes are available for some of these drugs.  

While this study is the first to show a dose response — meaning, the more you use anticholinergic medications the greater your risk of developing Alzheimer’s — it also is the first to suggest this higher risk may persist, and may not be reversible, even years after you stop taking these drugs. Visit Medical Daily for the study.



Xenex secures $25 million in funding

Xenex Disinfection Services announced it has secured $25 million in new funding. The financing includes new participation from Brandon Point Industries Limited and continued investment from existing investors including Battery Ventures, Targeted Technology Fund II and RK Ventures. The financing will be used for product development, international expansion and increasing the company's U.S. sales force.

A growing number of U.S. healthcare facilities are now evaluating new technologies for room disinfection as a means to eliminate the deadly pathogens that cause HAIs. Xenex’s patented pulsed xenon Full Spectrum ultraviolet (UV) disinfection technology is proven to quickly destroy the viruses, bacteria, mold, fungus and bacterial spores in healthcare facilities that cause infections.

There are now six peer reviewed studies confirming the efficacy of the Xenex Germ-Zapping Robot in the healthcare environment, including three studies showing a decrease in C.diff, MRSA and MDRO infections when the hospital used the Xenex robot for room disinfection.

Uniquely designed for ease of use and portability, a hospital’s environmental services staff can operate the Xenex robot without disrupting hospital operations and without using expensive chemicals.

With a five-minute disinfection cycle, the robot disinfects 30-62 hospital rooms per day (according to Xenex customers), including patient rooms, operating rooms, equipment rooms, emergency rooms, intensive care units and public areas. 

More than 250 hospitals, Veterans Affairs and DoD facilities in the U.S. are using Xenex robots, which are also in use in skilled nursing facilities, ambulatory surgery centers and long term acute care facilities. Visit Xenex for the details.



White House wants to nearly double funding to fight antibiotic resistance

President Obama's fiscal 2016 budget request will include a proposal to nearly double federal funding dedicated to combat antibiotic-resistant bacteria — a health issue that causes approximately 2 million illnesses and 23,000 deaths a year in the US. The increase would bring the total amount devoted to antibiotic resistance to $1.2 billion.

"The rise of resistance could hamper our ability to perform a range of modern medical procedures from joint replacements to organ transplants, the safety of which depends on our ability to treat bacterial infections that can arise as post-surgical complications," according to a White House statement.

In the new funding proposal, about $650 million will go to the NIH and the Biomedical Advanced Research and Development Authority to spur drug development, reports The Washington Post. Another portion of the funding, about $280 million, will be used to curb the over-prescribing of antibiotics in humans (about 50 percent of people who take antibiotics don't actually need them). Moreover, the Defense Department and the Department of Veterans Affairs will get a total of $163 million to combat antibiotic-resistant infections in settings that cater to veterans.

The White House's funding proposal appears to be a follow-up to a five-year plan it announced in September, aimed at slowing the spread of resistant bacteria. The plan directed the Department of Health and Human Services to come up with regulations requiring hospitals to set up antibiotic management programs. It also included the formation of a task force that is supposed to deliver a fully formed course of action by February 15th. In addition, it laid out incentives to pharmaceutical companies to try to kick-start drug development — but it mostly ignored the role of antibiotics in food production.

The announcement doesn't ignore the main consumers of antibiotics, 80 percent of antibiotics in the US are used on animals. $77 million will go to the Agriculture Department to develop alternatives to antibiotics used in farming. Another $47 million will be dedicated to evaluating new antibiotics — antibiotics like the newly discovered teixobactin, for instance — and monitoring antibiotic use in livestock production.

Doubling of the budget to fight antibiotic resistance might seem impressive at first blush, but $1.2 billion pales in comparison to the $4.9 billion that goes toward the National Cancer Institute each year. However, doubling the budget for antibiotics bucks the trend of declining research money; the US spending on science has slumped between 2004 and 2012. Particularly hard-hit were "proof-of-concept" studies, the early stage research that often focuses on new drugs — like new antibiotics.

The White House's full budget request will be submitted to Capitol Hill on February 2nd. Visit The Verge for the report.



Budget office slashes estimated cost of health coverage

The Congressional Budget Office on Monday significantly lowered its estimate of the cost of providing health insurance coverage to millions of Americans under the Affordable Care Act.

Douglas W. Elmendorf, the director of the budget office, said the changes resulted from many factors, including a general “slowdown in the growth of health care costs” and lower projections of insurance premiums that are subsidized by the federal government.

In March 2010, when President Obama signed the healthcare law, the Congressional Budget Office estimated that the expansion of coverage would cost the federal government $710 billion in the fiscal years 2015 through 2019, Elmendorf said.

“The newest projections indicate that those provisions will cost $571 billion over that same period, a reduction of 20 percent,” he said. The Affordable Care Act not only subsidized the purchase of private insurance, but also authorized a major expansion of Medicaid, the federal-state program for low-income people.

The new estimates may help Democrats trying to preserve the Affordable Care Act in the face of fierce criticism from Republicans, who control Congress and maintain that the law will contribute to explosive health spending.

On the other hand, several factors cited by the budget office may not be politically popular. For example, it said that a new excise tax on high-premium insurance, which takes effect in 2018, would generate substantial new revenue for the government — $149 billion in the first eight years. And it predicted that the number of people with employer-sponsored insurance would be lower than it would otherwise have been in the absence of the law.

Elmendorf estimated that the federal subsidies for private insurance purchased through public exchanges would total nearly $1.1 trillion from 2016 to 2025, while the federal government would spend $920 billion on Medicaid and the Children’s Health Insurance Program in those years as a result of the law. The subsidies in that 10-year period include $909 billion in tax credits and $147 billion to reduce deductibles and other out-of-pocket costs for low-income people.

The Obama administration said that 7.3 million people had bought private insurance through the exchanges and paid their share of premiums last year. The budget office predicts that this number will climb to 12 million in 2015 and will reach 25 million in 2017. About three-fourths of those subscribers are expected to receive federal subsidies, the budget office said.

That estimate underlines the importance of a case in front of the Supreme Court this term in which critics of the law are challenging subsidies paid to low- and moderate-income people in states that refused to establish their own exchanges. Visit the New York Times for the analysis.



Mississippi children's hospital plans $150 million expansion

JACKSON – University of Mississippi Medical Center officials say they're planning a $150 million expansion of Batson Children's Hospital to make room for more operating rooms, an imaging center, clinics and a revamped neonatal intensive-care unit.

Dr. James Keeton, vice chancellor for health affairs at the medical center, says that while the hospital doesn't need more general inpatient beds, it needs to expand elsewhere.

Gov. Phil Bryant endorsed the project in his State of the State speech. Bryant spokeswoman Nicole Webb said the governor supports state borrowing of $30 million to contribute to the project, at a rate of $10 million a year for three years.

UMMC is making a big push to increase private fundraising, with the support of the football greats Archie and Eli Manning. There's also a group that supports only Batson, Friends of Children's Hospital. It raised $1 million in the year ending June 30, 2013, according to a reporting form for tax-exempt organizations.

Keeton says UMMC has started planning a four-story building that would be constructed adjoining the current children's hospital. The project originally began as an effort to expand children's cardiac care, but Keeton said planning expanded to include other needs.

Among other needs are a renovation for Batson's neonatal intensive-care unit, one of the largest such operations in part because so many Mississippi babies are born with complications.

Last year, lawmakers agreed to borrow almost $230 million overall, including $30.5 million to continue construction of a new medical school building at UMMC. That's part of a multiyear commitment to finance the project, which aims to expand the number of physicians trained by the university. Visit Hattiesburg American for the story.



January 27, 2015   Download print version

Government to overhaul Medicare payments to doctors, hospitals

Travelers taking antibiotics may be helping spread of 'superbugs

Future of healthcare: Sensors will lead to highly personalized care

Stolen futures: The high cost of Alzheimer’s

Injectable epinephrine: An epidemic of misuse

ECRI Institute releases 2015 top 10 hospital C-Suite watch list

Mighty daily aspirin: New report says no one under 80 to experience cancer by 2050

Preparing for the unthinkable: Physician safety paramount following shooting of Boston surgeon

Government to overhaul Medicare payments to doctors, hospitals

Medicare will change the way it pays hospitals and doctors to reward quality over volume, the Obama administration said Monday, in a shift that officials hope will be a catalyst for the nation's $3 trillion healthcare system.

"It is in our common interest to build a healthcare system that delivers better care, spends healthcare dollars more wisely and results in healthier people," said Health and Human Services Secretary Sylvia M. Burwell.

The shift won immediate support from insurers and the American Hospital Association. The professional group representing primary care doctors also said it's "on board." But American Medical Association president Robert Wah stopped short of an endorsement, telling reporters his group is encouraged but wants specifics.

Burwell also announced the formation of the Learning and Action Network, a group she said will bring together a wide range of affected parties to drive change in how America pays for healthcare. It was unclear Monday whether the group will operate under federal open meetings rules. Its first meeting is planned for March.

Supporters say the ultimate goal is to promote and reward quality care, not just the sheer volume of services like imaging scans and some elective surgeries.

Medicare and employers were already moving in that direction, but Burwell's announcement sets specific federal goals and timetables.

Still, the outlook for the administration's initiative is unclear. Details of how the payment changes will be implemented remain to be spelled out. Building on experiments under the president's healthcare law, Burwell set a goal of tying 30 percent of payments under traditional Medicare to new models of care by the end of 2016. That would rise to 50 percent of payments two years thereafter.

HHS also set a goal of tying 85 percent of all payments under traditional Medicare to measures of quality or value by the end of 2016. That would rise to 90 percent two years thereafter. Some of those measures are already in effect. For example, hospitals with high rates of patients re-admitted within a month of being sent home face financial penalties.

The $2.9 trillion-a-year U.S. healthcare system remains at the forefront of scientific innovation globally. But there is widespread agreement that it costs the nation too much. Americans are no healthier than citizens of other economically advanced countries that spend less per person system. (Associated Press) Visit Seattle Times for the story.



Travelers taking antibiotics may be helping spread of 'superbugs

According to the Centers for Disease Control and Prevention (CDC), travelers' diarrhea is the most common illness to affect travelers. An estimated 10 million people - 20-50% of international travelers - develop the condition, usually occurring within the first week of travel.

In most instances, the use of antibiotics is unnecessary. "The great majority of all cases of travelers' diarrhea are mild and resolve on their own," states lead study author Dr. Anu Kantele.

The authors report that every year, around 300 million travelers visit regions where antimicrobial resistance is a growing risk. Of these travelers, more than 20% return to their home countries colonized by resistant intestinal bacteria.

Bacteria from the Enterobacteriaceae family can produce a particular enzyme in the gut called extended-spectrum beta-lactamase (ESBL). This enzyme is known to promote resistance to several frequently-used antibiotics.

The CDC state that ESBLs can be difficult to detect because they act in different ways to different forms of antibiotics. Bacteria that produce ESBLs are capable of causing dangerous infections that are harder and more costly to treat than many other infections.

For the study, published in Clinical Infectious Diseases, the authors analyzed stool samples from 430 Finns before and after traveling outside of Scandinavia for more than four nights to see how many contracted ESBL-producing bacteria while on their travels.

The researchers found that 21% of the participants contracted ESBL-producing bacteria while traveling. Risk factors identified for colonization were the region the participants traveled to, age, occurrence of travelers' diarrhea and use of antibiotics for the treatment of diarrhea.

Among participants taking antibiotics to treat their diarrhea, 37% became colonized. Among travelers visiting the riskiest region for resistant bacteria contraction - South Asia - 80% of those taking antibiotics for diarrhea contracted ESBL-producing bacteria.

None of the 90 travelers that were colonized by the bacteria went on to develop infections as a result, though the risk of the bacteria spreading from the travelers was still present. Dr. Kantele believes that a larger sample of colonized travelers would probably have yielded infection cases. Visit Medical News Today for the report.



Future of healthcare: Sensors will lead to highly personalized care

The future of health looks a lot like the fitness tracker you might already wear on your wrist or your waistband. But instead of just keeping tabs on your activity level, high-tech sensors embedded throughout your home, your car and maybe even under your skin will keep tabs on your every waking moment.

"A whole new day is coming," said Dr. Eric Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, considered a pioneer in the field of digital medicine. This near-continuous data dump will revolutionize our healthcare system, Topol predicted, and will lead to micro-personalization of our diets, workouts, homes and even medical treatments.

The upshot, he said, is that this data onslaught puts control of your health back where it belongs: with you.

His new book titled "The Patient Will See You Now," documents the looming power shift, courtesy of our smartphones.

Here's what it might look like: Light, temperature and movement sensors in your bedroom will help you craft night after night of deep, peaceful sleep, allowing you to wake rested and energized — and without an alarm clock.

A tricked-out bathroom scale might reflect not just your weight but also the air quality in your home, your stress level and your resting heart rate. An elevated heart rate could suggest a cold is on the way.

But if your heart rate is a beat or two lower, you'll know that your workout regimen — the one tailored for your precise fitness level, body shape and blood type — is progressing nicely. You'll polish your pearly whites with an electronic toothbrush that will tell you if you've brushed long enough or if you missed a spot, and will compile that information for your next dental visit.

Over the course of the day, you'll eat meals designed for your body type, family health history and fitness goals.

You'll be able to order blood panels and Skype with healthcare professionals halfway around the globe (and for a quarter of the price). And you can continuously monitor yourself — or a loved one, such as an aging parent — for key health markers such as blood pressure, glucose and hydration levels, inflammation, oxygenation and even the quality of your waste.

All those personalized data will be seamlessly harvested, synthesized and organized into a personalized dashboard that provides you — and anyone you choose — with the biofeedback you'll need to continually tweak and finesse your way to optimal health.

Experts say this "datafied" future will eliminate the gap between the haves and the have-nots when it comes to basic healthcare. As smartphones become widely available, healthcare becomes more widely available.

A microchip embedded in a pill could help document when someone takes — or fails to take — medication. The ability to monitor vital signs could even allow a stable patient to recuperate at home instead of in a hospital bed. Visit the Chicago Tribune for the story.



Stolen futures: The high cost of Alzheimer’s

Alzheimer's disease, the most common form of dementia, is hitting older communities such as Southwest Florida hard, overwhelming retirement savings and loading more costs onto the region's already strained medical system, a five-month News-Press investigation has found.

And population experts predict this is just the beginning. Barring a medical breakthrough, the nation — particularly states such as Florida — will see an explosion in dementia cases, driven largely by an aging baby boom generation and medical advances keeping people alive longer.

Today, an estimated 480,000 Floridians, including roughly 55,000 in Southwest Florida, have some form of it. The state's dementia population is expected to jump to 720,000 by 2025 with only California having more U.S. cases, according to the national Alzheimer's Association.

The disease will affect the old, who will have to endure it, and the younger generations, who will be forced to pay for that care. U.S. spending to treat and house Alzheimer's patients was an estimated $214 billion last year, more than the cost of treating heart disease or cancer. Taxpayer-supported Medicare and Medicaid accounted for 70 percent of that spending.

Dementia patients over the age of 65 are three times as likely to be hospitalized as seniors without the disease. They also spend more on medical and long-term care, and are nearly three times as likely to need taxpayer-supported Medicaid coverage. Meanwhile, research funding for Alzheimer's is less than the amounts spent on cancer, heart disease or HIV.

Dr. Fred Schaerf, a Fort Myers psychiatrist, Alzheimer's researcher and one of Florida's leading authorities on the disease, has been sounding the alarm for years. He said he worries not enough time and money are spent on finding a cure for Alzheimer's. "The disease is going to bankrupt the United States," Schaerf said. "Florida, especially Southwest Florida, is not ready for this in so many ways.”

The News-Press interviewed families in this region coping with the disease to find out how they are navigating the complicated, and costly, world of Alzheimer's treatment and long-term care. It also reviewed 10 years of public records from state agencies, nursing homes, clinics and hospitals to determine how much the disease is already straining medical resources and families' savings. Records for Southwest Florida include information from Lee, Collier, Charlotte, Desoto, Glades, Hardee, Hendry and Sarasota counties.

Medicaid spending for Alzheimer's-related care — primarily to pay for nursing home stays — has grown steadily in Southwest Florida to about $41.5 million in 2013, or about $40,000 per patient, according to Florida Agency for Healthcare Administration records. Statewide, Medicaid spends more than $517 million a year for these services, or about $32,000 per beneficiary. The Florida Agency for Health Care Administration did not comment when asked to explain such differences in cost.

The waiting list for caregiver assistance provided by state's Alzheimer's Disease Initiative had a waiting list in 2013 of about 2,000 people, according to state elder care advocates. (The state provided $4 million in additional ADI funding this year, which could reduce that number.)

Charges for Alzheimer's-related medical treatment at Southwest Florida's hospitals and clinics totaled more than $126 million in 2013, up from $55.5 million a decade ago, according to billing records collected by the state. The region's 10-year price tag for all such care: $981 million.

The public Lee Memorial Health System, which operates nearly 95 percent of the hospital beds in Lee County, hospitalized an average 1,200 Alzheimer's patients a year between 2007 and 2013 for a variety of medical reasons. The average bill: nearly $30,000 per patient. A typical hospital stay for all health system patients averages $28,639.

The average daily cost of nursing home care in Southwest Florida is $250, or $91,250 a year, without insurance. Most of these facilities allocate some beds to Medicaid patients and have special dementia-care units. But not all are locked for patient safety, and the waits to get in may take many months.

Medicare rates a quarter of these 71 facilities as "below average" or "much below average" for quality and care.

Alzheimer's patients live an average of four to eight years after they are diagnosed. Aside from the potentially high cost of daily supervision over those years, dementia patients require far more medical attention than most seniors. Medicare spends, on average, $10,748 for hospitalized dementia patients, compared to $4,321 for non-dementia patients, according to the Alzheimer's Association.

There are no acute-care medical units for Alzheimer's. Most hospitals, including those in Southwest Florida, are not specifically designed to deal with dementia patients, who may try to wander off or be otherwise combative. Often they are violent.

In a report last year, Florida Tax Watch warned of "Florida's Looming Alzheimer's Crisis" and called state research funding a "worthwhile, high-return investment."

Visit News-Press for the article.



Injectable epinephrine: An epidemic of misuse

It's time to face the fact that there is an epidemic of miscommunication about the use of epinephrine for allergic emergencies. This is a problem among both healthcare professionals and patients. As highlighted in report by Medscape Medical News, injectable epinephrine is often not used correctly by patients during allergic emergencies.

Studies have even found that most parents were afraid to use the device in their children with peanut allergy. And doctors don't get it right, either. R.S.H. Pumphrey reported, in a study, that epinephrine was administered in just 62% of the fatal anaphylactic reactions that he reviewed, with only a small minority (14%) receiving the drug before cardiac arrest.

It is epinephrine underuse that has consistently been shown to be the issue in anaphylactic emergencies, and overdose is actually quite rare. The standard adult dose of self-injecting epinephrine (0.3 mg of 1:1000 epinephrine) raises the level of epinephrine in the body from an average of 0.035 ng/mL to about 10 times that amount. It would require more about 20 such injections to reach a toxic level.

It's also important to note that a delay in use of epinephrine is linked to fatal food anaphylaxis. The other risk factor for fatal food reactions is poorly controlled asthma.

Finally, patients need to understand that allergic reactions are not all alike and that the severity may be influenced by many endogenous and exogenous factors. Factors that might accentuate an immediate hypersensitivity reaction include hormones, viral infections, nonsteroidal anti-inflammatory drugs, alcohol, and overheating/exercise. Visit Medscape for the article.



ECRI Institute releases 2015 top 10 hospital C-Suite watch list

From Google Glass to 3-D Printing, the ECRI 2015 Top 10 Hospital C-Suite Watch List arms healthcare professionals with evidence about new technologies entering the marketplace. ECRI Institute’s 2015 Top 10 Hospital C-Suite Watch List discusses a blend of novel, new, and emerging technologies that will demand attention and planning over the next 12 to 18 months, plus important issues and programs affecting care processes and delivery in 2015 and beyond. 

The top 10 include:

1.      Disinfection Robots: A Front-line Assault on Hospital-acquired Infections?

2.      Three-dimensional (3-D) Printing Buzz: How Many 2 3-D Printers Should You Plan on in 2015?

3.      Middleware Is Everywhere: Can It Help You Meet the National Patient Safety Goal on Clinical Alarms?

4.      Postdischarge Clinics: Do They Prevent Readmissions and Save You Money?

5.      Google Glass—Dead for Consumers but Maybe Not for Healthcare: Will Your Clinicians and Patients See Any Benefits?

6.      New Anti-obesity Devices: Should You Add Them to Your Bariatric Armamentarium?

7.      Caring for Millennials with Cancer: Should You Create Adolescent and Young Adult Cancer Centers to Improve Outcomes?

8.      Fecal Microbiota Therapy: New Hope for Other Serious GI Disorders?

9.      Artificial Pancreas Device Systems: What’s Coming after the First-generation System?

10.  Telehealth: Have We Passed the Tipping Point in Clinical Use?

Visit ECRI for the full report



Mighty daily aspirin: New report says no one under 80 to experience cancer by 2050

A new report has drawn quite a bit of attention with its eye-popping prediction that by as early as 2050 no one under 80 will experience cancer. The claim is tremendous, but the researchers from University College London (UCL) and King’s College London say they have the science to back it up.

In truth, death rates from cancer are a third down from 1996 and are expected to continue to drop. However, according to a report released from the University City London School of Pharmacy, these numbers will nearly disappear for those under 80 in a few decades, thanks to our increasingly effective prevention techniques. Report co-author Dr. David Taylor said healthy habits such as quitting smoking and taking a daily aspirin are helping to wipe out cancer, and 2050 was a “plausible guesstimate” of a time when cancer will only affect those over 80. 

"Taking aspirin daily looks to be the most important single thing we can do to reduce cancer after stopping smoking and reducing obesity, and will probably be much easier to implement," he told The Times. "What makes this a special point in history is that cancers are in the process of becoming either preventable or effectively curable."

Aspirin, while good at keeping cancer at bay, has been tied to increased chances of stomach bleeding. Dr. Jack Cuzick, director of the Wolfson Institute of Preventive Medicine at Queen Mary University in London says individuals should therefore consult their physician before taking the drug on a daily basis.

Although cancer is becoming far less deadly, a day when nearly no one dies from cancer is not yet here. Cancer prevention can only go so far, and a recent study has suggested that as many as 65 percent of cancer cases come from random genetic mutation that cannot be foreseen or stopped.

"When someone gets cancer, immediately people want to know why," said oncologist Dr. Bert Vogelstein of the Johns Hopkins University School of Medicine in Baltimore, who conducted the study, published in the journal Science, with Johns Hopkins biomathematician Cristian Tomasetti, Medical Daily reported.

While many dispute the exact figures of this number, the truth remains that some people get cancer not influenced by lifestyle or genetics.

On top of cancer being hard to predict, it’s also extremely hard to cure. There will most probably never be any one cure to cancer, and while science has become quite successful in treating some forms of cancer, such as skin cancer, for other forms of cancer, effective treatment remains elusive. One of the reasons for this is the unpredictable nature of the cancer cells. As reported by LiveScience, the cancer cells constantly change their DNA, which means that a method may only be able to prove effective on some cancerous cells. Cancer is also able to hide, rearing its ugly head years later. Visit Medical Daily for the article.



Preparing for the unthinkable: Physician safety paramount following shooting of Boston surgeon

Boston cardiac surgeon Dr. Michael Davidson, fatally shot by an individual with a suspected grudge against the physician, is a grim reminder that doctors can be harmed by anybody with a grievance and a weapon. And even though hospitals take physician and staff safety seriously, attempting to prepare for any and all situations, sometimes there's not a lot that can be done.

In fact, the Brigham and Women's Hospital, where Davidson was killed on Tuesday, January 20, 2015, had previously worked with the Boston Police Department to prepare for an "active shooter." The Brigham had even created its own training video for staff, teaching them to assess when it's appropriate to run, to hide, or to disable the suspect, according to the Boston Globe.

While hospital shootings are rare—one study reported there were 154 hospital-related shootings between 2000 and 2011, resulting in 235 dead or injured victims, with hospital employees constituting 20% of the victims—other problems do arise.

On the other side of the country, the Cleveland Clinic has its own fully commissioned police department, with officers certified by the State of Ohio. Started in 1987, the Cleveland Clinic Police Department is the third largest police agency in Northeast Ohio. Heather Phillips, the senior director of corporate communications, said that while most other hospitals rely on unarmed security officers, the Cleveland Clinic police consist of a mix of security and police officers with the authority to arrest individuals.

In the shooting of 44-year-old Dr. Davidson, Boston Police Commissioner William Evans said they responded to a 911 call at 11:07 am regarding shots fired at the Brigham and Women's Hospital. The suspect, 55-year-old Stephen Pasceri, was found by police in an examination room suffering from a self-inflicted gunshot wound. He was pronounced dead at the scene.

According to the police report, their preliminary investigation suggests Pasceri had an issue about the medical treatment of his mother at the hospital. Marguerite Pasceri died November 15, 2014 and was a patient of Dr Davidson's, according to media reports.

Pasceri was not known to the police previously and was legally licensed to carry a firearm. His neighbors expressed shock at his actions, describing him as a "calm, pleasant sort of guy" with four kids, reports the Boston Globe.

In 2010 at Johns Hopkins Hospital, the security staff came to a similar conclusion. The large Baltimore hospital felt metal detectors would be impractical, given that 80,000 patients and visitors pass through its doors each week and there are more than 80 entrances and exits. The hospital made this decision after a gunman had entered the facility and killed his mother and himself. Visit Medscape for the story.



January 26, 2015   Download print version

Deadly bacteria on medical scopes trigger infections

Data on payments from drugmakers to doctors is marred by error

HBI China 2015 promotes Sino-foreign business and academic exchange

Study rates migraine medications

Unhealthiness of sitting not offset by exercise: meta-analysis

Tide turning in Ebola fight after hard lessons

FDA clears new medical app to track real-time glucose levels in diabetics

HPN wants your Infection Prevention Success Stories

Deadly bacteria on medical scopes trigger infections

The deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh, and Chicago. In each case, the culprit was a bacteria known as CRE, perhaps the most feared of superbugs, because it resists even "last defense" antibiotics — and kills up to 40% of the people it infects.

And in each case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.

Yet neither the scopes' manufacturers nor the Food and Drug Administration, which regulates them, have publicized or offered guidance on the problem. So, many doctors who use the scopes — and most of the patients they treat — don't know the risks. Nor do they know that steps can be taken to cut those risks dramatically.

"Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that's got to change," says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County Public Health Department.

Many of the resulting infections may go unnoticed, says Duchin, who directed the investigation of the CRE outbreak in Seattle. In that case, seven patients died with infections that were associated with contaminated duodenoscopes; five of them with CRE.

When contaminated scopes transmit CRE, it's likely to get attention, because the infections involve especially perilous, "red-flag" bacteria, Duchin says. But more common bugs may elicit little more than a quick prescription for antibiotics — and no investigation. "There's a likelihood that we're just seeing a very small subset of the universe of infections from these types of scopes," Duchin says.

The FDA says in a written statement to USA TODAY that it is "aware of and closely monitoring" the infection risks associated with the scopes. "Some parts of the scopes may be extremely difficult to access and clean thoroughly," the agency adds, "and effective cleaning of all areas of the duodenoscope may not be possible."

The agency is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the scopes should be redesigned entirely. Meanwhile, the scopes' "lifesaving" ability to detect and treat potentially fatal digestive disorders outweighs their infection risks, the statement adds. "It (is) important for these devices to remain available."

Few dispute the scopes' importance. But public health officials and endoscopy experts who have studied the problem believe the FDA and scope manufacturers have been slow to bring attention to the infection risks and publicize steps hospitals can take to reduce them dramatically.

Most of the patients involved had undergone a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. In the procedure, the duodenoscope is used to inject a contrast dye into the bile and pancreatic ducts, of which X-rays are taken to reveal blockages, tumors, gallstones and other problems. The scope also can be used to gather material for biopsies, remove stones or other obstructions, or install stents to open the ducts.

Last year, after linking the CRE outbreak in Chicago to ERCP scopes, the Centers for Disease Control and Prevention issued a warning about the risks of spreading infections among patients who undergo the procedure. The problem, investigators found, is that biological material can collect in the "elevator" mechanisms that control tiny devices that extend from the tip of the duodenoscope.

Even when the devices are cleaned strictly in accordance with manufacturers' FDA-approved guidelines, "they have a lot of intricate mechanisms and pieces that are very difficult to disinfect," says Alex Kallen, an infectious-disease physician at the CDC who helped direct the investigation. "There definitely is a risk of (disease) transmission with these scopes."

Several hospitals that have linked CRE outbreaks to their duodenoscopes have not waited for guidance from the FDA and scope manufacturers; they've developed new safety procedures on their own that are showing great promise.

At Virginia Mason Medical Center in Seattle, officials adopted new scope-cleaning protocols and now require that all scopes be quarantined after cleaning, then tested for any residual bacteria before they can be reused.

The hospital had to purchase additional scopes, and more staff were needed for cleaning and testing, according to Duchin, the county health official. He says the changes cost the hospital an estimated $1 million, but the investment paid off: No infections have been linked to the scopes since the new procedures were put in place.

At University of Pittsburgh Medical Center and Advocate Lutheran General Hospital outside Chicago, officials have begun using EtO gas sterilization to ensure that any bacteria lingering on scopes after manual cleaning are destroyed. The process requires special facilities and equipment because the gas is toxic, but the hospitals have reported seeing no infections since they began using it.

The FDA says it is working with all three major manufacturers of duodenoscopes — Olympus, FUJIFILM and Pentax — to assess potential design changes and determine whether new disinfection processes can ensure the scopes' safety in their current configuration. Visit USA Today for the report.



Data on payments from drugmakers to doctors is marred by error

You’d think drug and medical device makers would know how to spell the names of their own products. But when companies submitted data to the federal government last year on their payments to doctors, some got the product names wrong. Forest Laboratories misspelled its depression drug, Fetzima, as “Fetziima” 953 times, in more than one-third of all the reports on the drug. Medical device company Amedica Corp. sometimes called its Preference screw system “Preferance.”

Amid much anticipation and after a lengthy delay, the government in September unveiled its Open Payments database, saying it would bring transparency to relationships between physicians and the drug and medical device industries. But this openness has been clouded by numerous errors that detract from its usefulness.

The database mistakes surfaced as an app was developed and rolled out this month with The Upshot, to identify the drugs and medical devices that were most heavily promoted to doctors in the last five months of 2013, the period covered by the data. The New York Times found that many of the drugs with the highest spending weren’t cures or even medical breakthroughs, but rather “me-too" drugs that were little different than other drugs on the market.

It was learned that the Centers for Medicare and Medicaid Services, which administers the Open Payments database, doesn’t double-check what companies submit.

“We are very committed to not altering data,” said Shantanu Agrawal, director of the agency’s Center for Program Integrity. “Our role is not to spell-check for the industry. The act of transparency also will improve the data itself.” As companies’ errors are exposed, he explained, they will work to fix them.

While misspelling product names was an obvious, infrequent error, a variety of other problems were discovered. Companies, for instance, routinely recorded payments associated with a single drug under multiple names.

Take H.P. Acthar Gel, an expensive injectable drug used to treat multiple sclerosis, kidney disease, lupus and other conditions. The drug’s maker, Questcor Pharmaceuticals, logged payments related to the drug under eight names, including Acthar, Acthar-Pulm, Acthar-IS, Acthar-Rheum and Acthar-MS. The payments associated with each name didn’t stand out much. But when they were all added together, the drug ranked in the top 20 for spending on doctors. For our analysis, we grouped them together.

Sanofi and Genzyme US Companies reported more than 31,800 payments totaling $1.7 million associated with Lantus, its long-acting insulin, but listed the drug under a variety of names: Lantus Timely Insulin, Lantus-Vial, Lantus TML and Lantus Capture Insulin.

Another complication was that about 8.5 percent of the 4.3 million general payments companies reported to the government were not connected to specific products. More than 140 companies did not list products at all in their payment records.

Other companies didn’t leave product fields blank but, in some cases, might as well have. Gilead Sciences listed the product associated with eight payments as “unrecognized” and connected two dozen more to “Gilead Corporate.” Novo Nordisk and its subsidiaries attributed 90 payments totaling $133,000 to a product called “Disease State,” a phrase that is physician talk for a medical condition like diabetes, not a particular drug.

It was also learned that some companies listed products in the wrong category, or listed them as both drugs and devices in the same payment records. Luitpold Pharmaceuticals Inc., a drug maker, did this in more than 8,000 payment records.

Companies were able to associate each payment with up to five drugs and five devices, so summing up spending by drug and device was tricky. When a payment was connected to more than one product, companies did not break out how much was attributable to each. Rather than guessing how to apportion such payments, ProPublica applied the full payment amount to each product. Since some companies routinely listed multiple drugs for individual payments, excluding such spending would have substantially distorted their totals.

Janssen Pharmaceuticals, a division of Johnson & Johnson, did this hundreds of times with its arthritis drug Simponi, listing it as both drug No. 1 and as drug No. 2 in records for the same payments. A company spokeswoman said although Janssen submitted the same name twice, the second reference was to Simponi Aria, a distinct product. As a result, code had to be written to count these payments only once.

In a number of cases, multiple subsidiaries of a company reported payments related to the same drugs. Five subsidiaries of Johnson & Johnson reported payments associated with the diabetes drug Invokana: Janssen Research & Development LLC; Johnson & Johnson Health Care Systems Inc.; Animas Corp.; Janssen Pharmaceuticals Inc. and LifeScan Inc.

There’s no indication that companies were being deliberately evasive — indeed, payments could have come from different subsidiaries. But the complexity shows how difficult it would be for the general public to get a true sense of payments from the publicly released data sets.

The Pharmaceutical Research and Manufacturers of America, the industry trade group, said mistakes were understandable since this had been the first year companies reported this information publicly and the government repeatedly changed its guidance for companies. Officials hope the coming year goes more smoothly. Data covering the full year 2014 is expected to be released this June. Visit the New York Times for the article.



HBI China 2015 promotes Sino-foreign business and academic exchange

The healthcare reform has brought about development opportunities for the Chinese healthcare market, and new challenges for the domestic and international hospital construction industry.

The Hospital Build & Infrastructure China (HBI China) Exhibition & Congress that will be held from May 23 – 25 at the Dalian World Expo Center once again reinforces its commitment towards promoting sino-foreign business and academic exchange, by presenting more comprehensive exhibition segments as well as diversified learning and networking platforms.

Since its inception in 2011, HBI China has been committed to the healthy and orderly development of the industry. Regarded as Asia’s flagship event for the hospital build and infrastructure industry, the integrated trade show provides industry players with the best platform for mutual exchange and cooperation between the government, and decision makers from hospitals and enterprises.

According to China’s State Council, the total scale of China's health service industry will exceed RMB 8 trillion by 2020, and over RMB 4 trillion will be invested in infrastructure. China’s healthcare industry is on its way to becoming the world's largest emerging market.

To address the market demand of China's health service industry, HBI China aims to promote the development and upgrade of China's medical and health service system. Centered on the theme of “Reform, Innovation, Development and Guidance”, HBI China 2015 will present a bigger and better show, with improvements in terms of size, service, effect, and overall quality. 

The 2015 edition is expected to attract close to 300 exhibitors and more than 15,000 professional visitors over three days.

The 16th China Hospital Construction Forum will also be held concurrently with HBI China 2015. As the most authoritative national academic conference in China's hospital construction industry, the forum will attract over 500 hospital construction project owners, bringing with them procurement requirements of over RMB 80 billion. At the forum, more than 2,600 core decision makers will be present, 85 percent of whom are involved in making procurement decision, including presidents and vice-presidents of hospitals, as well as chiefs of infrastructure divisions.

With over 200 distinguished industrial experts and over 100 top global hospital architects invited to speak at the forum, the 16th China Hospital Construction Forum will provide delegates with a quality academic exchange platform with the world’s top academic experts.

To learn more about the HBI China Exhibition and Congress 2015, visit www.hospitalbuildchina.cn/en/



Study rates migraine medications

The best medications to use if you suffer migraine headaches are listed in a new study. Researchers reviewed recent scientific literature and concluded that a number of classes of drugs were effective for treating acute migraine.

These include triptans, dihydroergotamine (DHE) and many NSAIDS (nonsteroidal anti-inflammatory drugs that include aspirin, ibuprofen and naproxen). Also on the list: butorphanol nasal spray, and the combination medications sumatriptan/naproxen and acetaminophen/aspirin/caffeine.

Several other medications are "probably effective" or "possibly effective," according to the study in the January issue of the journal Headache.

While powerful opioid pain drugs such as butorphanol, codeine/acetaminophen and tramadol/acetaminophen are likely effective migraine treatments, they are not recommended for regular use, the researchers said.

The study will form the basis of new American Headache Society guidelines for the treatment of migraine.

"We hope that this assessment of the efficacy of currently available migraine therapies helps patients and their physicians utilize treatments that are the most appropriate for them," said study co-author Dr. Stephen Silberstein in a society news release. He is a professor of neurology and director of the Jefferson Headache Center of Thomas Jefferson University in Philadelphia.

When selecting a medication for migraine patients, doctors must consider the medicine's effectiveness and possible side effects, the researchers said.

Migraines affect about 36 million Americans, according to the American Migraine Foundation. (HealthDay) Visit NIH for the study.



Unhealthiness of sitting not offset by exercise: meta-analysis

Greater sedentary time was associated with increased risk of adverse health outcomes including early death, even in those who otherwise exercised regularly, a meta-analysis indicated.

With data pooled from 41 primary research studies, researchers found that long periods of sitting time were positively correlated with all-cause mortality and other outcomes, after adjustment for levels of physical activity, compared with study participants reporting relatively little sitting time.

The risk was generally greater at lower levels of physical activity, according to David A. Alter, MD, PhD, at University Health Network in Toronto, and colleagues, writing in the Jan. 20 issue of Annals of Internal Medicine.

In an accompanying editorial, Brigid M. Lynch, PhD, and Neville Owen, PhD, both of the Baker IDI Heart and Diabetes Institute in Melbourne, Australia, wrote, "The implications of these findings are far-reaching. Sedentary behavior is ubiquitous. Society is engineered, physically and socially, to be sitting-centric."

Governments and professional organizations around the world are now warning that too much sitting can be hazardous to health, noted Lynch and Owen. But they also wrote that our understanding of how sitting affects cardiovascular disease is rudimentary.

"Understanding the mechanisms by which sedentary behavior increases risk for disease and the precise amounts of sitting that generate risk may enable us to more effectively characterize the most at-risk groups within the population," they said.

To help fill the research gap, they proposed three areas of research. Isotemporal substitution modeling, which looks at the difference in associations when time spent doing one behavior is altered by another activity while time is constant, could be used to look at the relative advantages of doing activities other than sitting.

In addition, future research should have objective activity monitoring, Lynch and Owen wrote. Most of the research done has been self-reported and looks at only one measure, like overall hours of sitting or total television viewing time. Researchers could use devices like inclinometers or accelerometers to track activity to reduce measurement error.

The meta-analysis included studies in which the sedentary time of adult participants was correlated to at least one health outcome independent of physical exercise. Sedentary behavior was defined as sitting, watching television, or lying down. Alter and colleagues excluded studies that reported indirect surrogate outcomes with unclear end points, like quality of life, metabolic biomarkers, and weight gain. Visit MedPage Today for the study.



Tide turning in Ebola fight after hard lessons

A top U.N. official in the fight against Ebola greeted just three patients at one treatment center he visited this week in Sierra Leone. Families in Liberia are no longer required to cremate the remains of loved ones to halt the spread of the virulent disease. And in the streets of Guinea's capital, it is rare to see the formerly ubiquitous plastic buckets of bleach and water for hand washing.

Ten months after it dawned on health officials that they were facing an unprecedented Ebola outbreak in West Africa, experts and officials agree the tide is turning, although previous lulls have proved short-lived.

There is still no vaccine or licensed treatment, nor is it clear whether the international community has actually learned any lessons from an epidemic that killed at least 8,675 people.

Previous disease outbreaks, including SARS and bird flu, prompted calls to build strong health surveillance systems and to reinforce agencies like the World Health Organization. But little has changed.

After the 2009 swine flu pandemic, WHO commissioned an independent review, which recommended creating a $100 million emergency fund for health crises and beefing up rapid-response health experts. Neither has been done.

The human toll of Ebola can be starkly seen in one plot of land in Liberia's capital where only Ebola victims are buried now. Cards placed on sticks and stuck into the ground carry the names of those who died. One day, families hope they will be replaced with concrete gravestones marking the years of birth and death as sunrise and sunset.

"Recriminations are counterproductive, but it will be necessary to understand whether this outbreak could have been responded to quicker with less cost and less suffering," U.N. Ebola chief, Dr. David Nabarro, told the U.N. General Assembly earlier this week

"The epidemic has turned," Ismael Ould Cheikh Ahmed, the new head of the U.N. Mission for Ebola Emergency Response known as UNMEER, recently declared. The number of cases in Guinea and Sierra Leone is at its lowest since August, and in Liberia it's the lowest since June. Still, he and other officials caution that they lack critical information about the cases that do remain. Only about half of new cases in Guinea and Liberia are from known contacts, meaning that the remainder is getting infected from unknown sources.

No such statistics even exist for Sierra Leone, where deaths are still being underreported because families want to carry out burials in accordance with tradition, which involves touching bodies — one of the quickest ways to spread Ebola

The outbreak has not killed as many people as some predictions. At its height, one estimate warned that as many as 1.4 million people could become infected by mid-January if there were no additional interventions. Instead, the probable, suspected and confirmed case toll is 21,797 with 8,675 deaths.

Nearly every agency and government stumbled in its response to Ebola, now expected to cost the three most-affected countries at least $1.6 billion in lost economic growth in 2015.

In an internal draft document obtained by The Associated Press last year, WHO acknowledged there was "a failure to see that conditions for explosive spread were present right at the start." WHO blamed incompetent staff and said it let bureaucratic bungles delay people and money to fight the virus. The document said the agency was hampered by budget cuts and the need to battle other diseases flaring around the world.

Officials must also think about changing risky cultural practices in future epidemics, said Dr. Peter Piot, director of the London School of Hygiene and Tropical Medicine and co-discoverer of the Ebola virus. (Associated Press) Visit ABC News for the story.



FDA clears new medical app to track real-time glucose levels in diabetics

Doctors and other caregivers will soon be able to track the blood-sugar levels of diabetic patients by simply logging into a smartphone app, in the latest example of how mobile technologies are changing the health care landscape.

The Food and Drug Administration on Friday approved the first set of glucose-monitoring medical apps aimed at automatically and securely sharing data in real time. The system, produced by California-based Dexcom Inc., includes a small, wire-like sensor inserted just under the skin that continuously transmits data to a monitor that is worn externally.

Using the company's smartphone app, the patient can then designate "followers" with whom to share their information. The app then receives real-time data and transmits it to an Internet-based storage location, where the follower can also download and view the information via the app. While other similar app systems exist, Friday's approval marks the first of its kind since the FDA started regulating certain medical apps as devices in the fall of 2013.

The FDA's marketing approval for Dexcom's system could pave the way for similar technologies. Because the app was approved as a "low- to moderate-risk" medical device, other manufacturers that want to market a similar app in the future won't need to receive prior clearance from the agency. They will, however, have to register their product with the FDA.

The agency has made clear that it does not intend to crack down on the majority of health-related mobile apps -- of which there are thousands, because most pose little risk to consumers. But in its 2013 guidance, the FDA said it would regulate a subset of mobile apps "that present a greater risk to patients if they do not work as intended."

Visit the Washington Post for the announcement.



HPN wants your Infection Prevention Success Stories

Healthcare Purchasing News wants to share your Infection Prevention Success Stories. We will be selecting and including the most effective and innovative stories in our April 2015 feature. Below are some ideas that would tell our readers about your facility's success story:

·         What specific infection was your facility aiming to reduce or eliminate, and why was it chosen for the focus of the campaign?

·         When did your facility start this campaign to reduce or eliminate this specific infection?

·         What was the rate of this infection before your facility began their campaign to reduce or eliminate it?

·         What is the rate of infection currently, or at the end of the study?

·         Have they been able to sustain the reduced rate of infection?

·         Describe specific steps your facility took to reduce or eliminate this infection.

·         If a product(s) was part of the solution, identify it and explain how it contributed to reduction/elimination of this specific infection.

·         What department(s) was involved in formation and implementation of this campaign? Was teamwork involved?

·         Did those charged with the task meet with any resistance by administration or staff in implementing the changes? If so, how did they overcome it?

Please include how you quantified your successes with numbers and percentages, monetary savings, time savings, and patient safety enhancement figures. The deadline is February 5, 2015. Please send stories to editor@hpnonline.com.  

Visit here for the success stories from 2014.



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